(88 days)
Not Found
No
The description focuses on mechanical components and fluid transfer for cleaning, with no mention of AI/ML terms or functionalities.
No
The device is described as a cleaning pump for endoscopic instruments, designed to remove debris and facilitate a sanitary environment for extensive cleaning. It does not exert any medical or therapeutic effect on a patient.
No
The device is described as a flushing/cleaning pump intended to remove debris from endoscopic instruments, which is a cleaning function, not a diagnostic one.
No
The device description explicitly states it is "composed of a variety of medical grade plastics" and describes physical components like a "threaded connector" and "dual check valve," indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as cleaning Biosearch Endoscopic Instruments. This is a cleaning and maintenance function for a medical device, not a diagnostic test performed on a biological sample.
- Device Description: The description focuses on the mechanical aspects of the pump and its function in facilitating the flow of cleaning fluid. There is no mention of analyzing biological samples or providing diagnostic information.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or treatment decisions based on biological sample analysis.
The device is a cleaning accessory for an endoscopic instrument, which falls under the category of medical device maintenance, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The Syringe Flushing/Cleaning Pump is intended to clean the Biosearch Endoscopic Instruments. The Syringe Flushing/Cleaning Pump is a device that helps remove debris that may get trapped inside the Biosearch Endoscopic Instrument.
Product codes (comma separated list FDA assigned to the subject device)
Not Found
Device Description
The Disposable Syringe Flushing/Cleaning Pump for Biosearch Endoscopic Instruments, is a similar design to an existing legally marketed device. It is composed of a variety of medical grade plastics. The threaded connector is especially designed to fit the flushing port of the Biosearch Endoscopic device which impedes water leakage during the cleaning process. The dual check valve is an important feature because it provides an efficient transfer of the water, and/or cleaning fluid. This will provide a sanitary environment for the medical health professional to perform the extensive cleaning of the Biosearch Endoscopic Instruments.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
medical health professional; Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.
0
Image /page/0/Picture/1 description: The image shows the logo for Biosearch Medical Products Inc. The logo is in black and white and features the word "biosearch" in a bold, sans-serif font. The "i" in "biosearch" is dotted with a stylized image of a flask. Below the word "biosearch" is the phrase "MEDICAL PRODUCTS INC." in a smaller, sans-serif font.
MAR - 3 1997
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> 510(k) SUMMARY SAFFETY & EFFECTIVENESS SUMMARY
BIOSEARCH SYRINGE FLUSHING/CLEANING PUMP FOR BIOSEARCH ENDOSCOPIC INSTRUMENTS
Manufactured / Sold by:
Biosearch Medical Products, Inc. 35 Industrial Parkway P.O. Box 1700 Somerville, NJ. 08876 {USA}
Telephone : 1-908-722-5000 Fax : 1-908-722-5024
Contact Person:
R. Soubra
POLAN SOUBRA
AN SOUBRA
Assistant to the Vice President of New Product Development Coordinator
12/2/96
date submitted
P.O. Box 1700 Somerville, NJ. 08876-1276 (USA) Biosearch Medical Products, Inc. FAX: 908-722-5024 TEL: 908-722-5000
1
Biosearch Medical Products, Inc. -- 510(k) submission for: BIOSEARCH SYRINGE FLUSHING/CLEANING PUMP FOR BIOSEARCH ENDOSCOPIC INSTRUMENTS
INTENDED USE STATEMENT: The Syringe Flushing/Cleaning Pump is intended to clean the Biosearch Endoscopic Instruments.
The Syringe Flushing/Cleaning Pump is a device that helps remove debris that may get trapped inside the Biosearch Endoscopic Instrument.
DESCRIPTION OF THE DEVICE:
The Disposable Syringe Flushing/Cleaning Pump for Biosearch Endoscopic Instruments, is a similar design to an existing legally marketed device. It is composed of a variety of medical grade plastics.
The threaded connector is especially designed to fit the flushing port of the Biosearch Endoscopic device which impedes water leakage during the cleaning process.
The dual check valve is an important feature because it provides an efficient transfer of the water, and/or cleaning fluid. This will provide a sanitary environment for the medical health professional to perform the extensive cleaning of the Biosearch Endoscopic Instruments.
Image /page/1/Figure/7 description: The image shows a diagram of an endoscopic device with a syringe and directional valve. The diagram includes labels for the different parts of the device, such as the endoscope, threaded portion, discharge line, directional valve, syringe, and flushing medium. The principle of operation is described, explaining how the syringe plunger is used to fill the syringe with fluid and how the directional valve allows the fluid to pass through the discharge line to the endoscope.
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Biosearch Medical Products, Inc. -- 510(k) submission for: BIOSEARCH SYRINGE
FLUSHING/CLEANING PUMP FOR BIOSEARCH ENDOSCOPIC INSTRUMENTS
| NAME
&
510(K) No. | For Cleaning
Endoscopic
Instruments | Connects to
the proximal
port | Uses a syringe to pump
cleaning fluid |
|----------------------------------------------------------------------------------------------------------------|-------------------------------------------|-------------------------------------|------------------------------------------|
| BIOSEARCH
"BiosearchFlushing/Cleaning
Pump for Biosearch
Endoscopic Instruments"
{This submission} | YES | YES | YES |
| MILL-ROSE
"Cleaning Adapter"
{K922204} | YES | YES | YES |
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PAGE 1
SAFETY & EFFECTIVENESS SUMMARY Biosearch Medical Products, Inc. BIOSEARCH SYRINGE FLUSHING/CLEANING PUMP FOR BIOSEARCH ENDOSCOPIC INSTRUMENTS
NO PATIENT CONTACT
| MATERIAL | TEST DATE | TEST PERFORMED | RESULTS |
|---|---|---|---|
| PolyVinyl Chloride | Vendor Supplied | USP tests for Systemic | |
| Injection Test, Intracutaneous | |||
| Injection Test, Implantation | |||
| test | Meets the | ||
| requirements of USP | |||
| Class VI Plastic | |||
| Polyurethane | |||
| Tecothane™ | |||
| TT-1080A | 6/26/91-6/28/91 | MEM Elution Test | Meets the |
| requirements of the | |||
| Elution Test, USP | |||
| XXII for the Elution | |||
| Test | |||
| Polyurethane | |||
| Tecothane™ | |||
| TT-1080A | 6/14/91-6/29/91 | Biological Test for Plastics | |
| Class VI | Meets the | ||
| requirements of the | |||
| USP XXII for the | |||
| Biological Test of | |||
| Plastic | |||
| Polyurethane | |||
| Pellethane2363 | |||
| Series | Vendor Supplied | Acute Systemic Toxicity, | |
| Intracutaneous Toxicity, | |||
| Implantation Test | Meets the | ||
| requirements of the | |||
| USP Class XI | |||
| Polycarbonate | |||
| HPS2-1125 | Vendor Supplied | Cytotoxity, Hemolysis, | |
| Implantation, USP Class V | |||
| Extractables, USP | |||
| Physicochemical-Plastics | Meets the | ||
| requirements of | |||
| Class VI in Vivo & | |||
| in Vitro Biological | |||
| Reactivity, USP | |||
| Physicochemical- | |||
| Plastic | |||
| Dow Corning RX50 | |||
| CT Silastic Ribbon | Cytotoxity, Hemolysis, | ||
| Implantation, USP Class V | |||
| Extractables, USP | |||
| Physicochemical-Plastics | Meets the | ||
| requirements of | |||
| Class VI in Vivo & | |||
| in Vitro Biological | |||
| Reactivity, USP | |||
| Physicochemical- | |||
| Plastic | |||
| MATERIAL | TEST DATE | TEST PERFORMED | RESULTS |
| Alpha PVC 2212/7 | |||
| 118 RSI Clear | 6/20/88 | ||
| 6/18/84-6/25/84 | |||
| 6/20/84 | USPXX Systemic Injection Test | ||
| USPXXIntramuscular implantation, | |||
| USP XX Intracutaneous Test, | |||
| Direct Exposure Cytoxicity Test | Meets the USP | ||
| Class VI requirements | |||
| Cyrolite® | |||
| G20-300-001 | Vendor Supplied | Systemic Toxicity, | |
| Intracutaneous Toxicity, | |||
| MEM Elution, Hemolysis, | |||
| Pyrogen, Guinea Pig Max. | |||
| Implantation Test | Meets the USP | ||
| Class VI requirements | |||
| Cyrolite® | |||
| G20-100-001 | Vendor Supplied | Systemic Toxicity, | |
| Intracutaneous Toxicity, | |||
| Implantation Test | |||
| Hemolysis, MEM Elution | |||
| Pyrogen, Guinea Pig Max. | Meets the USP | ||
| Class VI requirements | |||
| Radel R-5100 | Vendor Supplied | Systemic Toxicity, | |
| Intracutaneous Toxicity, | |||
| Implantation Test | Meets the USP | ||
| Class VI requirements | |||
| Silastic Medical | |||
| Grade {7-4735, | |||
| 7-4750, 7-4765} | Vendor Supplied | Hemolysis, Intracutaneous | |
| Injection, Systemic Injection | |||
| Intramuscular Implant | Meets the USP | ||
| Class VI Plastic Tests | |||
| Silastic Biomedical | |||
| Grade Liquid | |||
| {Q-7-480, 6860} | Vendor Supplied | Hemolysis, Skin Sensitization | |
| USP Class V Extractables | Passes the Hemolysis | ||
| Skin Sensitization,& | |||
| USP Class V | |||
| Extractables Tests |
: ・
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